The IPL sapphire cooling hair remove device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

AI/ML Overview

This document describes the safety and performance testing for the "IPL sapphire cooling hair remove device" (Model: LB06) by Shenzhen Desida Technology Co., Ltd. for its 510(k) submission (K221635). The testing primarily focuses on safety rather than clinical efficacy for hair removal, as the device is determined to be substantially equivalent to previously cleared predicate devices for its intended use.

Here's a breakdown of the requested information based on the provided document:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility Safety:
- ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity	Passed
- ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization	Passed
Electrical Safety:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility	Passed
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance	Passed
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment	Passed
- IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment	Passed
Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems	Passed
Software Verification and Validation:	All software requirement specifications met; all software hazards mitigated to acceptable risk levels.

Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for any clinical test set, as the performance data provided focuses on laboratory and engineering safety tests (biocompatibility, electrical safety, eye safety, and software validation). No clinical study on human subjects is detailed for the subject device to prove its hair removal efficacy, likely due to substantial equivalence to predicate devices already cleared for that indication. The tests mentioned are likely conducted in a lab environment in China, given the manufacturer's location. The provenance is internal company testing to meet international standards.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable (N/A) for the types of tests described. These are standardized engineering and biological safety tests, typically evaluated against established international standards rather than expert consensus on a test set.
Adjudication Method for the Test Set:
N/A. The evaluation methods for these standards are defined within the standards themselves, not through an adjudication process among experts in the context of this document.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study was done or reported in this document. The submission relies on substantial equivalence to predicate devices for its intended use, rather than a direct clinical comparative effectiveness study against human readers or other devices for improved performance.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
A standalone software validation was done, demonstrating that "all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This is a standalone assessment of the device's software function, not a standalone clinical performance study.
The Type of Ground Truth Used:
For the safety tests (biocompatibility, electrical, eye), the "ground truth" is defined by the specific requirements and pass/fail criteria outlined in the referenced international standards (e.g., ISO 10993-5, ISO 10993-10, IEC 60601 series, IEC 62471). For software, the ground truth is the "software requirement specifications." There is no clinical "ground truth" (like pathology or outcomes data) mentioned for hair removal efficacy for this specific device in this document, as it relies on substantial equivalence for that claim.
The Sample Size for the Training Set:
N/A. As this document describes evaluation for substantial equivalence through safety and engineering tests, there is no mention of a "training set" in the context of machine learning or AI models for clinical outcomes. The device is an IPL hair removal device, not an AI diagnostic tool.
How the Ground Truth for the Training Set Was Established:
N/A for the same reasons as #8.

Summary

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August 31, 2022

Shenzhen Desida Technology Co., Ltd. % Rain Yip Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address

Re: K221635

Trade/Device Name: IPL sapphire ice cooling hair remove device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: May 26, 2022 Received: June 6, 2022

Dear Rain Yip:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221635

Device Name

IPL sapphire cooling hair remove device, model: LB06

Indications for Use (Describe)

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

Date: 2022-05-26

I. Submitter

Shenzhen Desida Technology Co., Ltd.

5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoan District, Shenzhen City, Guangdong Province, China

Post code: 518109

Tel.: +86 755 2822 7189

Shuangcheng Yuan

RD engineer

Tel: +86 755 2822 7189

Email: 184056776@qq.com

II. Device

Name of Device: IPL sapphire cooling hair remove device Model: LB06

Model: LBU6

Common or Usual Name: Light Based Over-The-Counter Hair Removal

Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II

Product Code: OHT

Regulation Number: 21 CFR 878.4810

III. Predicate Device

Primary predicate device: 510(k) number: K210311 Manufacturer: Shenzhen Mismon Technology Co.,Ltd. Trade name: Home Use IPL Beauty Device, MS-216B Product code: OHT Approval date: 07/23/2021 Predicate device II: 510(k) number: K161565 Manufacturer: STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Trade name: DUO, IPL-HH380-IT Product code: OHT, ONF Approval date: 09/01/2016 Predicate device III:

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510(k) number: K221001 Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd. Trade name: IPL Home Use Hair Removal Device, D-1198 Product code: OHT Approval date: 05/12/2022

IV. Device Description

V. Indications for Use

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

VI. Comparison of Technological Characteristics With the Predicate Device

The subject device IPL sapphire cooling hair remove device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the subject device may be found substantially equivalent to its predicate devices.

The subject device is compared with the following Predicate Devices in terms of intended use, design, specifications, and performance:

ComparisonElements	Subject Device	Primary predicatedevice K210311	Predicate deviceII K161565	Predicate deviceIII K221001
K Number	Pending	K210311	K161565	K221001
Trade name	IPL sapphire haircooling remove device/LB06	Home Use IPLBeauty Device/MS-216B	DUO/IPL-HH380-IT	IPL Home UseHair RemovalDevice/D-1198
Wavelengthrange	640-1200nm	510-1100nm	480-1200nm	530-1100nm
Energy medium	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp
Energy density	$3.0~5.1J/cm^2$	$2.5~4.5J/cm^2$	$5J/cm^2$ Max.	$2.0~4.3J/cm^2$
Spot size	3.3cm2	3.0cm2	3.0cm2	2.7cm2
Pulse duration	16~24ms	9~12ms	<20ms	5~12ms
ComparisonElements	Subject Device	Primary predicatedevice K210311	Predicate deviceII K161565	Predicate deviceIII K221001
Pulsing control	Finger switch	Finger switch	Finger switch	Finger switch
Delivery device	Direct illuminationto tissue	Direct illumination totissue	Directillumination totissue	Directillumination totissue
Indicationforuse/Intended use	IPLsapphirecoolinghairremove device isanover-the-counterdeviceintendedforremovalofunwantedbodyhair.	The Home Use IPLBeauty Device is anover-the-counterdevice intended forremoval of unwantedhair such as but notlimited to small areassuch as underarmand facial hair belowthe chin line andlarge areas such aslegs.	TheDUO(Model:IPL-HH380-IT) is anover the Counterdevice intendedfor the removal ofunwanted bodyand/or facial hairin adults.TheDUO is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as thelong-term stablereduction in thenumber of hairsregrowing whenmeasured at 6. 9.and 12 monthsafter thecompletion of atreatmentregimen.	IPL Home UseHair RemovalDevice is an over-the-counterdevice intendedfor removal ofunwanted bodyand/or facial hair.
Location for use	OTC	OTC	OTC	OTC

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VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Safety

The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:

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ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

3) Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Summary

Based on the above performance as documented in this application, the subject device IPL sapphire cooling hair remove device was found to have a safety and effectiveness profile that is similar to the predicate device.

VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device IPL sapphire cooling hair remove device is to be concluded substantial equivalent to its predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.